(58 days)
Vatech Clismile is indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth.
It is used to correct teeth by transmitting physical force to each tooth, and is a selfligation bracket using a ceramic body and a metal cap made of a metal material. Shelf-life is not applicable because of the low likelihood of time-dependent product degradation.
The provided text describes a 510(k) premarket notification for a medical device called "Vatech Clismile," which is an orthodontic bracket. The document focuses on demonstrating substantial equivalence to a predicate device, "In-Ovation C." The information does not present a study with detailed acceptance criteria and performance reports in the context of an AI/ML powered device. Instead, it focuses on the equivalence of physical and materials characteristics.
Therefore, many of the requested fields cannot be filled as they pertain to the evaluation of an AI-powered medical device through clinical or performance studies with ground truth establishment, which is not the subject of this document.
However, I can extract the relevant information regarding the technical characteristics and the performance testing mentioned to demonstrate equivalence.
Here's the information based on the provided text, with many fields marked as "Not applicable" due to the nature of the document.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative sense as might be expected for software or AI performance, but rather focuses on equivalence of physical/material properties and adherence to relevant standards.
| Acceptance Criteria Category | Specific Criteria / Standard | Device Performance (Vatech Clismile) | Predicate Device (In-Ovation C) | Conclusion |
|---|---|---|---|---|
| Material Composition | Bracket (Body) | Polycrystalline Alumina (100%) | Polycrystalline Alumina (100%) | Same |
| Door | Nickel-Cobalt Alloy (100%) | Nickel-Cobalt Alloy (100%) | Same | |
| Transparency | Aesthetic property | Half-transparency | Half-transparency | Same |
| Bracket Design | ISO 27020:2010 compliance | MBT, ROTH designs with/without hook; Conforms to ISO 27020:2010 | MBT, ROTH designs with/without hook; Conforms to ISO 27020:2010 | Same |
| Self-ligating mechanism | Presence/Absence | Yes | Yes | Same |
| Orientation marking | Presence/Absence | Yes | Yes | Same |
| Packaging | Sterility | Non-sterile packaging | Non-sterile packaging | Same |
| Dimensions (In-out) | Range (mm) | 1.05 to 1.54 | 1.05 to 1.55 | Similar |
| Torque | Range (°) | -11 to +17 | -11 to +17 | Same |
| Angulation | Range (°) | 0 to 13 | 0 to 13 | Same |
| Slot Sizes | Available options | 0.022 inch | 0.018" / 0.022 inch | Similar |
| Dimensional Analysis | ISO 27020 & Comparison to Predicate | Dimensions confirmed to be the same within error range (for specific models) | - | Same within error range |
| Biocompatibility | ISO 10993-5 (cytotoxicity) | Evaluation report available | - | Met |
| ISO 10993-10 (sensitization) | Evaluation report available | - | Met | |
| ISO 10993-11 (systemic toxicity) | Evaluation report available | - | Met | |
| Material Safety | ISO 22674 (hazardous element & corrosion for metal cap) | Evaluation report available | - | Met |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Specific sample sizes are not explicitly stated for all tests. For "Dimensional analysis," specific models "Clismile 12-1223" and "IN-OVATION C H100-132-81" (corresponding to the maximum canine) were used for comparative assessment. The document states "Bracket generally uses a one-kit product consisting of 20 brackets." and that "Clismile is also composed of the same number of sets" as the predicate.
- Data Provenance: Not specified, but the manufacturing company is Rayence Co., Ltd. from Gyeonggi-do, Korea. The tests are likely internal company evaluations or performed by accredited labs.
- Retrospective/Prospective: Not specified, but given the context of a 510(k) submission, these would be controlled tests performed for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This document does not describe a study involving expert readers or establishment of ground truth in a clinical assessment context. The evaluations are primarily engineering and materials performance tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. (No expert adjudication involved for this type of technical performance testing).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-powered device and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the tests performed is based on:
- Engineering specifications and measurements (e.g., dimensions, torque, angulation).
- Material composition analysis.
- Standardized test methods (e.g., ISO 27020 for brackets, ISO 10993 series for biocompatibility, ISO 22674 for metallic materials).
- Direct comparison to the predicate device's established characteristics.
8. The sample size for the training set
Not applicable. There is no AI/ML model for which a training set would be required.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML model.
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.